Primary Percutaneous Coronary InterventionNCT07175181
Impact of Gut Microbiota on Clinical Outcomes and Left Ventricular Remodeling After Primary Percutaneous Coronary Intervention
An observational study of Primary Percutaneous Coronary Intervention, run by Assiut University.
Trial summary
Left ventricular remodeling (LVR) refers to the structural and functional changes that occur in the left ventricle following myocardial injury. These changes can include alterations in left ventricular shape, size, wall thickness, and volume, which can ultimately lead to decreased cardiac function and increased risk… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Primary Percutaneous Coronary Intervention
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines.
Who may be able to join
- Age ≥ 18 years .
- Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines.
- Patients scheduled to undergo primary PCI for STEMI.
- Ability and willingness to provide informed consent for participation and for the collection of stool samples.
- No significant comorbidities that may confound the results (e.g., chronic kidney disease, liver cirrhosis).
- No prior use of antibiotics, probiotics, or prebiotics within the last 3 months, as these may significantly alter gut microbiota composition.
- Willingness and ability to complete follow-up assessments as required by the study protocol.
- Absence of major gastrointestinal disorders (e.g., inflammatory bowel disease, gastrointestinal infections) that could affect gut microbiota.
Who cannot join
- Age < 18 years.
- Chronic Diseases:
- Chronic kidney disease (stage 3 or higher).
- Chronic liver disease (e.g., cirrhosis).
- Active malignancies.
- Acute infections or active inflammatory conditions at the time of PCI.
Show all 13Show fewer
- Gastrointestinal Disorders:
- Inflammatory bowel disease.
- Celiac disease.
- Diverticulitis.
- Recent use of antibiotics, probiotics, or prebiotics within the last 3 months.
- Use of immunosuppressive medications or chemotherapy.
- Uncontrolled diabetes or hypertension.
About this study
Left ventricular remodeling (LVR) refers to the structural and functional changes that occur in the left ventricle following myocardial injury. These changes can include alterations in left ventricular shape, size, wall thickness, and volume, which can ultimately lead to decreased cardiac function and increased risk of heart failure. The remodeling process is often maladaptive and can worsen the prognosis of patients with CAD. Recent advances in microbiome research have unveiled the critical role of gut microbiota in modulating systemic health, including cardiovascular health. The gut microbiome consists of trillions of microorganisms that engage in complex interactions with the host, influencing various physiological processes. Among these interactions is the production of metabolites that can directly affect cardiovascular physiology. Notably, Trimethylamine N-oxide (TMAO). Elevated TMAO levels have been associated with increased risk of atherosclerosis and cardiovascular events, including those following PCI. Data suggest that TMAO may promote endothelial dysfunction and enhance inflammatory pathways, thereby exacerbating vascular injury and LV remodeling. These findings indicate that the interaction between gut microbiota composition, TMAO production, and cardiovascular risk could represent a novel therapeutic target for improving patient outcomes after PCI . Understanding the dynamics of these relationships can provide critical insights into individualized treatment strategies and dietary interventions that may mitigate cardiovascular risk.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma levels of Trimethylamine N-oxide (TMAO)
Measurement: Plasma levels of Trimethylamine N-oxide (TMAO) will be quantified before or after PCI, using ELISA kits or other validated methods.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Gamal AbdelHakam, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175181
- Sponsor's protocol ID
- Microbiota PCI
- Status last verified
- Sep 2025
- First submitted
- 9 Sep 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Gut Microbiota on Clinical Outcomes and Left Ventricular Remodeling After Primary Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT07175181
- Acronym / sponsor ID
- Microbiota PCI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Left ventricular remodeling (LVR) refers to the structural and functional changes that occur in the left ventricle following myocardial injury. These changes can include alterations in left ventricular shape, size, wall thickness, and volume, which can ultimately lead to decreased cardiac function and increased risk of heart failure. The remodeling process is often maladaptive and can worsen the prognosis of patients with CAD. Recent advances in microbiome research have unveiled the critical role of gut microbiota in modulating systemic health, including cardiovascular health. The gut microbiome consists of trillions of microorganisms that engage in complex interactions with the host, influencing various physiological processes. Among these interactions is the production of metabolites that can directly affect cardiovascular physiology. Notably, Trimethylamine N-oxide (TMAO). Elevated TMAO levels have been associated with increased risk of atherosclerosis and cardiovascular events, including those following PCI. Data suggest that TMAO may promote endothelial dysfunction and enhance inflammatory pathways, thereby exacerbating vascular injury and LV remodeling. These findings indicate that the interaction between gut microbiota composition, TMAO production, and cardiovascular risk could represent a novel therapeutic target for improving patient outcomes after PCI . Understanding the dynamics of these relationships can provide critical insights into individualized treatment strategies and dietary interventions that may mitigate cardiovascular risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –patients Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines.
Key inclusion criteria (8 listed)
- Age ≥ 18 years .
- Confirmed diagnosis of ST-elevation myocardial infarction (STEMI) and indication for PCI based on clinical guidelines.
- Patients scheduled to undergo primary PCI for STEMI.
- Ability and willingness to provide informed consent for participation and for the collection of stool samples.
- No significant comorbidities that may confound the results (e.g., chronic kidney disease, liver cirrhosis).
Key exclusion criteria (13 listed)
- Age < 18 years.
- Chronic Diseases:
- Acute infections or active inflammatory conditions at the time of PCI.
- Gastrointestinal Disorders:
- Recent use of antibiotics, probiotics, or prebiotics within the last 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma levels of Trimethylamine N-oxide (TMAO)
Time frame: baseline
Measurement: Plasma levels of Trimethylamine N-oxide (TMAO) will be quantified before or after PCI, using ELISA kits or other validated methods.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Percutaneous Coronary Intervention, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma levels of Trimethylamine N-oxide (TMAO) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.